Confirmation Needed: Whether Bone Marrow Stem Cell Injections for Knee Osteoarthritis Have Received Government Approval as a New Medical Technology
It is necessary to confirm whether bone marrow stem cell injections for the treatment of knee arthritis have been approved as a new medical technology by the government. Concerns about patient harm from unlicensed bone marrow cell extractors. Government approval of new medical technology is needed. [Medical Newspaper/Daily Newspaper = Reporter Lee Sang-man] The Ministry of Health and Welfare recognized “bone marrow stem cell injection,” which uses cells extracted from the bone marrow of patients with osteoarthritis of the knee and directly injects them into damaged knees to safely promote cartilage regeneration, protect, and treat the condition, as a new medical technology in July. Smart Mcell + Bone Marrow Kit BMSC, approved as a stem cell Patients with knee arthritis can receive medical benefits through actual cost insurance if they meet the eligibility criteria for bone marrow stem cell injection therapy. However, it’s important to note that not all stem cell treatments are created equal. First, it’s important to note that the stem cell injections listed as a new medical technology by the Ministry of Health and Welfare are derived from bone marrow, not fat. Confirmation of whether the injection is a bone marrow stem cell injection is necessary, followed by the biosystem and dedicated kit for stem cell extraction. It’s crucial to verify that the devices and kits used in clinical trials of this new medical technology are indeed used. Using a kit that doesn’t specifically mention stem cells or that doesn’t comply with the approved specifications is incompatible with bone marrow stem cell therapy, which is recognized as a new medical technology. An official from the legal team of Miracell, which directly applied for registration of this new medical technology and manufactured the Smart M-Cell and bone marrow kit used in clinical trials, explained, “First of all, stem cells used to treat patients with knee osteoarthritis must be listed as ‘bone marrow stem cells’ in the MFDS approval. To do this, they must undergo an equivalence evaluation with a previously approved device as specified in the Regulations on Approval, Reporting, and Review of Medical Devices (MFDS Notice No. 2023-39, Article 3, Paragraph 11).” He continued, “The Ministry of Food and Drug Safety (MFDS) determines approval through a process that verifies the intended use, operating principle, raw materials, performance, testing specifications, and method of use of a medical device that has already been approved and certified. The problem is that stem cell extraction systems and kits from companies that do not meet these criteria are being indiscriminately used to treat patients with knee osteoarthritis.” He continued, “Recently, some hospitals are using kits that are identical to blood kits, but with only a bone marrow acupuncture needle attached. These kits cost between 300,000 and 500,000 won. Kit models that have not been used in clinical trials for new medical technologies have not been proven to have a viability and recovery rate for cells, which is crucial for stem cell therapy. This could render the procedure unrelated to stem cells.” Bone marrow stem cell injections for knee arthritis are listed as new medical technologies and are therefore eligible for non-coverage insurance benefits. However, there has been controversy recently over a medical institution that has been charging high fees for procedures using unproven stem cell extraction devices and kits, claiming they have advanced equipment and hospitalization facilities. Meanwhile, an official from B Insurance Company expressed concern, saying, “In accordance with the ‘Revised Best Practices for Insurance Fraud Prevention’ announced by the Financial Supervisory Service in April of last year, we are tightening our insurance claim review standards to prevent excessive treatment for non-covered items. However, if the number of hospitals and clinics abusing the new medical technology of bone marrow stem cell injections for knee arthritis to incur excessive claims increases, they will become targets for the insurance industry and this could negatively impact patient claims payments.” Source: Medical Newspaper (http://www.bosa.co.kr/)